Senior Scientist Analytical Development

Job Description – Senior Scientist 1

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. The Analytical Sciences department supports all assay needs in Tech Ops. Our 50+ Scientists and Research Associates are experts in analytics of small molecules, peptides, proteins/enzymes, and gene therapy agents. We develop assays to follow the quality attributes of our products, support IND and BLA applications, and assess the capability of our production processes. We develop release assays and are responsible for lot release and stability testing for early-stage clinical programs (tox, development, GMP lots), and support assay transfer to Quality for late-stage programs. We are also instrumental in time-critical analysis support to Manufacturing as needed. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

The Analytical Sciences department at BioMarin Pharmaceutical Inc. is seeking a Senior Scientist 1 with core expertise in molecular and cellular biology along with biochemistry or immunology experience. The selected candidate will focus on delivering release and characterization methods for adenovirus associated virus (AAV) vectors developed for gene therapy to address genetic disorders. The successful candidate will be a self-motivated critical thinker, with a proven ability to work in a multi-disciplinary and collaborative environment. The candidate will develop and utilize a wide variety of analytical methods for the release and characterization of gene therapy vectors in our pipeline including cell-based assays, molecular biology assays, and biochemical or immunology-based assays. An ideal candidate would be well-versed in methods to modify and analyze reporter cells used for bioassays, methods to analyze expression and activity of transduced genes, impurity assays for analysis of viral vector products, and experience with generation and characterization of cell models and cell banks used for bioassays. Prior experience in analytical development projects for CMC is desired.

RESPONSIBILITIES

• Execution of relevant experiments to support development of qualitative and quantitative assays for gene therapy process development as well as product characterization
• Primarily support development, qualification, and transfer of biochemical, immunological, and molecular methods relevant for gene therapy vectors and cell-based analytics.
• Conduct experiments to support vector characterization, safety studies, comparability studies, and stability studies in a timely fashion
• Routinely share experimental data with project teams and write test procedures, critical reagent development and characterization protocols, qualification protocols and reports, and assess routine testing performance as needed
• Train colleagues and associates when needed
• Potential to serve as CMC analytical team leader for early and/or late-stage products, depending on performance and other departmental objectives

EXPERIENCE

Required Skills:

• Expert in advanced molecular biology and cell biology 
• Highly proficient in biochemistry and/or immunology
• Highly skilled in developing novel analytical methods to characterize cellular responses to various culture conditions
• Experience with development of viral vector characterization and release assays
• Exceptional experimental design, analysis, and interpretation skills
• Exceptional collaborative skills effective within a cross-functional environment
• Strong verbal and written communication skills
• Strong organizational and documentation skills
• Proven flexibility and execution skills to deliver in a fast-paced environment
• Organizational and strategic skills relevant for CMC and Analytical Sciences
• Skilled in analytical method investigations, optimization for late-stage programs, and comparability studies

Desired Skills:

• Modification and qualification of cells for bioassays
• Functional characterization of cellular processes (differentiation, transport, etc.)
• Automation of experimental processes and data analysis
• Prior experience with critical reagent processes and qualifications

EDUCATION AND EXPERIENCE

Education fields and work experience in cell biology, virology, or molecular biology. Individuals with biochemistry or immunology education and experience will also be considered. Direct training and laboratory experience with viral vectors is required.

PhD or equivalent relevant experience plus 5+ years industry experience; MS with 10+ years; BS with 12+ years. 

EQUIPMENT

Operation of standard PCR, ddPCR, qPCR, plate readers, confocal microscope, HPLC, flow cytometry, automation (imaging, liquid handling), and other common laboratory equipment is required.

CONTACTS

Will report to the Principal Scientist managing a cell-based analytics group functioning to develop potency, virology, immunochemistry, and molecular assays for Analytical Sciences.

SUPERVISOR RESPONSIBILITY

Potential for supervisory role is dependent upon prior experience and performance.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.